FDA approves new formulation, indication for Merck’s Dificid

The Food and Drug Administration has approved a new formulation and a new indication for Merck’s Dificid (fidaxomicin). The new formulation is Dificid for oral suspension, and the expanded indication, for Dificid tablets, is for the treatment of clostridioides difficile-associated diarrhea, or CDAD in children ages six months old and older.

“C. difficile is an important cause of health care- and community-associated diarrheal illness in children, and sustained cure is difficult to achieve in some patients. The fidaxomicin pediatric trial was the first randomized controlled trial of C. difficile infection treatment in children,” said Larry Kociolek, associate medical director of infection prevention and control at Ann & Robert H. Lurie Children’s Hospital of Chicago. “I am very excited to have a new C. difficile infection treatment option for my pediatric patients.”

“Merck is committed to developing new treatments, as well as expanding indications of existing ones, in order to provide more solutions to treat infectious diseases, particularly among children,” said Nicholas Kartsonis, senior vice president, clinical research, infectious diseases and vaccines, Merck Research Laboratories. “C. difficile infection is an urgent public health challenge. We are grateful to the health care practitioners, the patients and their families for their invaluable contributions in helping to bring this new pediatric indication and the oral suspension formulation for Dificid to the U.S. market."